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HeartWare Battery recallZ-1266-2022 · Medtronic Inc · initiated May 5, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and no longer provide power or prevent the battery from holding a complete charge or properly recharging.

FDA root cause category: Process control

What the company is doing

In the United States, on 5/5/2022, a written Medical Device Retrieval letter dated May 2022 was mailed via 2-day UPS delivery to consignees who have received potentially affected product according to Medtronic records. Outside of the US (OUS), beginning 5/5/2022, an Urgent Medical Device Retrieval letter was being delivered via regionally approved methods to consignees who have received potentially affected product according to Medtronic records. The letter notified customers of the issue description and were provided patient management recommendations. This included reminding their patients to always keep two sources of power connected to their controller and have fully charged spare batteries available at all times. If a [Power Disconnect] alarm occurs while a battery is physically connected, that battery should be taken out of service. The letter references instructions from the patient manual. The consignee actions included immediately identifying and quarantining all affected batteries listed in the attachment; immediately notify patients with affected batteries that Medtronic is conducting this retrieval and have them remove these batteries from service; informed the consignee that the Medtronic Field Representative can assist them in the return of the affected product; complete and return the enclosed Customer Confirmation Form and follow the instructions to initiate an exchange; and share the letter with all those who need to be aware within their organization or to any organization where the affected batteries have been transferred.

Recall details

Recall number
Z-1266-2022
Status
Open, Classified
Initiated by the company
May 5, 2022
Recalling firm
Medtronic Inc
Quantity
429 batteries
Product code
DSQ
FDA submissions
P100047
Distribution
Worldwide Distribution. US nationwide, Austria, Belgium, Finland, France, Germany, Hungary, Italy, Netherlands, New Zealand, North Macedonia, Norway, Poland, Spain, Switzerland, and the United Kingdom.

Product description

HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.

Code information (models, lots, serial numbers)

Show the full code information (5k characters)

GTIN 00888707008778. Serial numbers BAT935012, BAT935059, BAT935008, BAT935009, BAT935018, BAT935020, BAT935022, BAT935023, BAT935047, BAT934999, BAT935003, BAT935010, BAT935329, BAT934928, BAT934934, BAT935160, BAT935078, BAT934997, BAT935027, BAT935048, BAT934953, BAT934933, BAT934948, BAT934853, BAT934854, BAT934858, BAT934895, BAT934899, BAT934901, BAT934903, BAT934904, BAT934905, BAT934927, BAT934932, BAT934935, BAT934940, BAT934979, BAT934981, BAT935109, BAT935112, BAT935116, BAT935117, BAT935120, BAT935122, BAT935124, BAT935127, BAT935132, BAT935133, BAT935134, BAT935136, BAT934846, BAT934848, BAT934849, BAT934850, BAT935137, BAT935142, BAT935143, BAT935145, BAT935146, BAT935148, BAT935150, BAT935151, BAT935152, BAT935154, BAT935155, BAT935156, BAT935157, BAT935158, BAT935161, BAT935162, BAT935163, BAT935164, BAT935260, BAT935301, BAT935302, BAT935303, BAT935201, BAT935202, BAT935203, BAT935172, BAT935173, BAT935174, BAT935175, BAT935176, BAT935177, BAT935178, BAT935179, BAT935180, BAT935181, BAT935182, BAT935183, BAT935184, BAT935185, BAT935186, BAT935187, BAT934910, BAT934912, BAT934914, BAT934915, BAT934916, BAT934919, BAT935317, BAT935318, BAT935319, BAT935320, BAT935322, BAT935324, BAT935217, BAT935264, BAT935269, BAT935276, BAT935277, BAT935282, BAT935283, BAT935285, BAT935286, BAT935287, BAT935312, BAT935313, BAT935314, BAT935188, BAT935189, BAT935190, BAT935191, BAT935192, BAT935193, BAT935194, BAT935195, BAT935196, BAT935197, BAT935198, BAT935199, BAT934851, BAT934852, BAT934855, BAT934857, BAT934859, BAT934861, BAT934862, BAT934863, BAT934865, BAT934866, BAT935207, BAT935210, BAT935222, BAT935256, BAT935257, BAT935230, BAT935231, BAT935233, BAT935234, BAT935236, BAT935237, BAT935238, BAT935268, BAT935270, BAT935271, BAT935272, BAT935273, BAT935275, BAT935279, BAT935280, BAT935288, BAT935290, BAT935291, BAT935292, BAT935284, BAT934844, BAT935229, BAT934917, BAT934918, BAT934920, BAT934924, BAT935232, BAT935235, BAT935247, BAT935261, BAT934867, BAT934868, BAT935265, BAT935266, BAT935204, BAT935205, BAT935206, BAT935212, BAT935213, BAT935216, BAT935250, BAT935251, BAT935252, BAT935253, BAT935254, BAT935267, BAT934869, BAT935200, BAT935262, BAT935218, BAT935219, BAT935227, BAT935228, BAT934871, BAT934873, BAT934874, BAT934875, BAT934876, BAT934877, BAT934878, BAT934880, BAT934881, BAT934882, BAT934883, BAT934884, BAT934886, BAT934909, BAT935138, BAT935140, BAT935293, BAT935294, BAT935296, BAT935259, BAT935297, BAT935298, BAT935299, BAT935300, BAT934894, BAT935326, BAT935331, BAT934982, BAT934987, BAT934988, BAT934989, BAT935032, BAT935038, BAT935039, BAT935040, BAT935042, BAT935043, BAT935051, BAT935068, BAT935074, BAT935085, BAT935089, BAT935093, BAT935094, BAT935095, BAT935098, BAT935099, BAT935100, BAT935101, BAT935102, BAT935103, BAT935104, BAT935105, BAT935106, BAT935107, BAT935108, BAT935141, BAT935144, BAT935147, BAT935149, BAT935159, BAT935165, BAT935166, BAT935167, BAT935168, BAT935169, BAT935170, BAT935171, BAT935258, BAT934887, BAT934889, BAT934891, BAT934893, BAT934870, BAT935239, BAT935240, BAT935241, BAT935242, BAT935243, BAT935244, BAT935245, BAT935246, BAT935248, BAT935249, BAT934906, BAT934908, BAT935033, BAT935036, BAT935044, BAT935017, BAT935045, BAT935001, BAT935026, BAT935114, BAT935118, BAT935121, BAT935123, BAT935263, BAT935274, BAT935278, BAT935281, BAT935315, BAT935084, BAT935086, BAT934896, BAT934897, BAT934898, BAT934949, BAT934950, BAT935323, BAT935325, BAT935327, BAT935328, BAT935330, BAT935332, BAT935005, BAT935006, BAT935025, BAT935062, BAT935064, BAT935065, BAT935208, BAT934922, BAT934926, BAT934929, BAT934930, BAT934942, BAT934943, BAT934944, BAT934945, BAT934955, BAT934959, BAT934961, BAT934964, BAT934967, BAT934968, BAT934969, BAT934970, BAT934976, BAT934977, BAT934978, BAT935002, BAT935014, BAT935049, BAT934973, BAT934974, BAT935087, BAT935091, BAT935097, BAT934962, BAT935041, BAT935046, BAT935050, BAT935053, BAT935057, BAT935058, BAT935061, BAT935063, BAT935067, BAT935071, BAT935077, BAT935080, BAT935081, BAT935088, BAT935090, BAT935092, BAT934952, BAT934954, BAT934958, BAT934921, BAT934923, BAT934925, BAT934931, BAT934941, BAT934951, BAT935015, BAT935016, BAT935019, BAT935021, BAT935096, BAT935111, BAT934998, BAT934956, BAT935024, BAT935028, BAT935034, BAT935037, BAT935069, BAT935070, BAT935215, BAT935321, BAT935135, BAT935029, BAT935030, BAT935031, BAT934946, BAT934983, BAT934984, BAT934986, BAT934992, BAT934971, BAT934972, BAT934975, BAT934980, BAT934995, BAT935000, BAT935007, BAT935013, BAT934947, BAT934996, BAT935011, BAT935052, BAT935054, BAT935056, BAT935082, BAT935072, BAT935073, BAT935075, BAT935076, BAT935004, BAT934990, BAT934991, BAT934993, BAT934994, BAT935079, BAT934985, BAT934963, BAT934965, and BAT934966. Expiration date 30-APR-22.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

32 devices cleared under P100047 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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