Class II Recall

HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104

Summary

The FDA issued a Class II for HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Numbe by Heartware, Inc.. Reason: Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responde.

Details

Source

Device Recall

External ID

Z-1102-2022

Action Date

2022-05-25

Status

Ongoing

Product Description

HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104

Lot/Code Info: GTIN 00888707000598, Serial Numbers: HW28827 GTIN 00888707001649, Serial Numbers: HW29474, HW29864, HW29985, HW30222, HW31506, HW31511, HW32021, HW32255, HW32301, HW34343, HW35068, HW35085, HW35290, HW35311, HW35349, HW35559, HW35657, HW35662, HW35664 GTIN 00888707002424, Serial Numbers: HW29480, HW29696, HW30650, HW30766, HW30767, HW31698, HW31851 GTIN 00888707004558, Serial Numbers: HW34759, HW34785, HW35655, HW35656 GTIN 00888707006323, Serial Numbers: HW34982, HW35722, HW36082, HW36189, HW36297, HW36375, HW36452, HW36539, HW36605, HW36649, HW36687, HW36740, HW36798, HW36865, HW37202 GTIN 00888707005951, Serial Numbers: HW35887, HW35893 GTIN 00888707006347, Serial Numbers: HW36040, HW36048, HW36049, HW36050, HW36051, HW36052, HW36053, HW36054, HW36055, HW36088, HW36089, HW36092, HW36093, HW36094, HW36095, HW36096, HW36097, HW36100, HW36101, HW36102, HW36103, HW36105, HW36106, HW36107, HW36108, HW36109, HW36110, HW36111, HW36112, HW36170, HW36540, HW36541, HW36542, HW36543, HW36544, HW36565, HW36566, HW36568, HW36569, HW36570, HW36571, HW36572, HW36573, HW36574, HW36575, HW36576, HW36577, HW36578, HW36579, HW36581, HW36582, HW36583, HW36584, HW36585, HW36586, HW36611, HW36612, HW36615, HW36616, HW36618, HW36619, HW36620, HW36621, HW36622, HW36623, HW36808, HW36809, HW36810, HW36918, HW36946, HW36948, HW36949, HW36950, HW36951, HW36952, HW36953, HW36954, HW36955, HW36956, HW36959, HW36960, HW36961, HW36962, HW36963, HW37006, HW37007, HW37008, HW37009, HW37010, HW37154, HW37155, HW37156, HW37157, HW37161, HW37162, HW37164, HW37165, HW37166, HW37168, HW37169, HW37263, HW37358, HW37378, HW37381, HW37386, HW37387, HW37432, HW37434, HW37440, HW37447 GTIN 00888707003209, Serial Numbers: HW41915, HW41916, HW41918, HW41919, HW41945, HW41946, HW41947, HW41948, HW41978, HW41979, HW41981, HW41982, HW41983, HW41984, HW41988, HW41990 GTIN 00888707002486, Serial Numbers: HW30860, HW30835, HW30807, HW30817, HW30861, hw30795, hw30800, HW30663, hw30794, HW30662, hw30793, HW30664, hw30799, HW30516, hw30798, HW30514, HW30522, HW30518, HW30517, HW30391, HW30361, HW30401, HW30362, HW30396, HW30405, HW30395, HW30389, HW30394, HW30359, HW30141, HW30142, HW30140, HW30135, HW30143, HW30136, HW30144, HW30139, HW30137, HW29759, HW29762, HW29758, HW29765, HW29760, HW29757, HW29770, HW29771, HW29768, HW29769, HW29795, HW29747, HW29752, HW29734, HW29750, HW29749, HW29746, HW29748, HW29025, HW29432, HW29442, HW29446, HW29344, HW29482

Quantity Affected: 236 units

Reason for Recall

Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.

Distribution

Finland and Turkey

Type: Voluntary: Firm initiated

Recall Initiated: 2022-03-30

Company

Heartware, Inc.

Miami Lakes, FL

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Heartware, Inc. has 39 FDA actions in our database, including 39 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Heartware, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Heartware, Inc. have FDA actions?

Heartware, Inc. has 39 FDA actions in our database, including 39 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1102-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

Want to know the moment something like this happens?

Get alerts for device

Related Actions

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200

Covidien LP · 2023-08-23

Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO

MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15

VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri

Boston Scientific Corporation · 2024-09-25

EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo

Enchroma Inc · 2024-11-27

Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;

Adept Medical Ltd · 2025-01-29