OT:RR:CTF:VS H349573 AP
Robert Kroslowitz, CEO
Berlin Heart, Inc.
9391 Grogans Mill Rd
The Woodlands, TX 77380-3628
RE: Pediatric Ventricular Assist Device; 9817.00.96, HTSUS
Dear Mr. Kroslowitz:
This is in response to your May 15, 2025 ruling request, submitted on behalf of Berlin
Heart, Inc. (“importer”), regarding the applicability of subheading 9817.00.96, Harmonized
Tariff Schedule of the United States (“HTSUS”), to the Berlin Heart EXCOR® Pediatric
Ventricular Assist Device (“VAD”) of subheading 9021.90.81, HTSUS.
FACTS:
The EXCOR® Pediatric Ventricular Assist Device is a mechanical circulatory support
system designed for children, from newborns to adolescents, with life-threatening heart failure
after all conservative therapeutic options have been exhausted. The VAD improves
hemodynamics and end-organ function and is used as a bridge to cardiac transplantation. The
VAD is used for short to long-term support of the left and/or right ventricular pumping function.
The VAD consists of one or two blood pump(s), cannulas (including inflow and outflow
cannulas), polyvinyl chloride (“PVC”) driving tubes, and a stationary driving unit (“Ikus”) or
mobile driving unit (“EXCOR® Active”). The pumps are connected to cannulas that are sewn
onto the child’s heart. Their function is to support the left or right or both sides of the child’s
heart. A machine outside of the child’s body (Ikus or EXCOR® Active) is used to make the
pumps move blood through the child’s heart. The removal of the VAD takes place in the
operating room and the procedure requires medication.
Typically, the child will receive a heart transplant when the VAD is removed. The
average time children are on the device in the United States is 85 days. 1 The longest duration of
1
See EXCOR® Pediatric, The Gold Standard in Pediatric VAD Therapy at 3, EXCOR_Pediatric_-
_The_Gold_Standard_in_Pediatric_VAD_Therapy_MFE41.3_Oktober_2018.pdf (last visited Aug. 8, 2025).
support is 2.5 years for toddlers and 3.5 years for adolescents. 2 Children implanted with the
VAD receive a heart transplant, are taken off the VAD and do not need a heart transplant or die
before they could receive a heart transplant. At one year, 60 percent of the patients are
transplanted, and 10 percent are weaned. 3 The U.S. Food and Drug Administration (“FDA”) has
approved the VAD under a Humanitarian Device Exemption (intended for use in less than 4,000
people). Since 1990, 166 pediatric heart centers in 37 countries have used the VAD and more
than 1,700 pediatric patients have been implanted with the device. 4
ISSUE:
Whether the VAD is eligible for subheading 9817.00.96, HTSUS, treatment.
LAW AND ANALYSIS:
The Nairobi Protocol to the Agreement on the Importation of Educational, Scientific and
Cultural Materials of 1982, Pub. L. No. 97-446, 96 Stat. 2329, 2346 (1983) established the duty-
free treatment for certain articles for the handicapped. Presidential Proclamation 5978 and
Section 1121 of the Omnibus Trade and Competitiveness Act of 1988, provided for the
implementation of the Nairobi Protocol into subheadings 9817.00.92, 9817.00.94, and
9817.00.96, HTSUS.
Subheading 9817.00.96, HTSUS, covers: “Articles specially designed or adapted for the
use or benefit of the blind or other physically or mentally handicapped persons; parts and
accessories (except parts and accessories of braces and artificial limb prosthetics) that are
specially designed or adapted for use in the foregoing articles . . . Other.”
U.S. Note 4(a), subchapter XVII, Chapter 98, HTSUS, states that, “the term ‘blind or
other physically or mentally handicapped person’ includes any person suffering from a
permanent or chronic physical or mental impairment which substantially limits one or more
major life activities, such as caring for one’s self, performing manual tasks, walking, seeing,
hearing, speaking, breathing, learning, or working.” In Headquarters Rulings Letters (“HQ”)
557025, Mar. 17, 1993, and HQ 557027, dated Mar. 17, 1993, U.S. Customs and Border
Protection (“CBP”) concluded that individuals suffering from heart problems which mandated
the use of pacemakers were considered physically handicapped. Similarly, children with severe
isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant
and require circulatory support are physically handicapped persons under U.S. Note 4(a),
subchapter XVII, Chapter 98, HTSUS.
U.S. Note 4(b), subchapter XVII, Chapter 98, HTSUS, excludes four categories of
articles from subheading 9817.00.96, HTSUS treatment: “(i) articles for acute or transient
disability; (ii) spectacles, dentures, and cosmetic articles for individuals not substantially
disabled; (iii) therapeutic and diagnostic articles; or, (iv) medicine or drugs.”
2
See id.
3
See id.
4
See id. at 2.
2
In HQ 557302, dated Mar. 17, 1993, an implantable dual chamber pacemaker was not a
therapeutic article because it did not heal or cure the underlying heart condition of the
handicapped persons who utilized it but “merely control[ed] and help[ed] those individuals adapt
to their handicapped conditions.” As such, the implanted pacemaker was not precluded from
duty-free treatment as a “therapeutic” article under U.S. Note 4(b), HTSUS.
More recently in HQ H331366, dated Mar. 24, 2025, CBP distinguished internal
pacemakers/defibrillators from external defibrillators primarily used to evaluate and treat an
acute or transient disability such as an acute cardiac event and concluded that unlike implanted
pacemakers, external defibrillators are articles for acute disability and are excluded from
subheading 9817.00.96, HTSUS.
Similar to implanted pacemakers, the VAD is an implanted device that helps individuals
adapt to their handicapped condition. The cannulas are secured to the child’s heart and blood
vessels with stitches and once the cannulas are sewn to the heart they are connected to the blood
pumps, which stay outside the child’s body. The VAD is removed in the operation room
typically when the child receives a heart transplant. Thus, the VAD is not a “therapeutic” article
under U.S. Note 4(b), HTSUS.
We also need to determine whether the VAD is an article for acute or transient disability
precluded from treatment under 9817.00.96, HTSUS. In HQ 563142, dated Feb. 18, 2005, CBP
concluded that even though individuals with acute disabilities such as sprained ankles could
utilize the canes, the articles were of the class or kind predominately used by permanently or
chronically handicapped individuals and were eligible to receive treatment under subheading
9817.00.96, HTSUS.
Here, the VAD may be used short-term, but it is designed for children with end-stage
heart failure, which is not a transient disability. The VAD is used solely for the purpose of
providing the heart’s pumping function to children with severe isolated left ventricular or
biventricular dysfunction who typically need a heart transplant and are physically handicapped
persons under U.S. Note 4(a), subchapter XVII, Chapter 98, HTSUS. Severe heart problems that
require heart transplants or mechanical support for the pumping function are permanent or
chronic impairments, not transient disabilities, even though once children receive healthier donor
hearts, the VAD needs to be surgically removed. The fact that the VAD acts as a bridge to heart
transplant does not remove the children’s long-term mobility limitations and other impairments.
Under these circumstances, we find that the VAD was clearly designed for, and is
predominantly used by, children with permanent or chronic physical handicaps, and is eligible
for subheading 9817.00.96, HTSUS treatment.
HOLDING:
The subject VAD is eligible for subheading 9817.00.96, HTSUS treatment.
Please note that 19 C.F.R. § 177.9(b)(1) provides that “[e]ach ruling letter is issued on the
assumption that all of the information furnished in connection with the ruling request and
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incorporated in the ruling letter, either directly, by reference, or by implication, is accurate and
complete in every material respect. The application of a ruling letter by [CBP] field office to the
transaction to which it is purported to relate is subject to the verification of the facts incorporated
in the ruling letter, a comparison of the transaction described therein to the actual transaction,
and the satisfaction of any conditions on which the ruling was based.”
A copy of this ruling letter should be attached to the entry documents filed at the time this
merchandise is entered. If the documents have been filed without a copy, this ruling should be
brought to the attention of the CBP officer handling the transaction.
Sincerely,
Monika R. Brenner, Chief
Valuation and Special Programs Branch
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