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Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual… recallZ-0651-2024 · Abiomed, Inc. · initiated Nov 7, 2023

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 Abiomed, 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

Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

FDA root cause category: Process control

What the company is doing

Abiomed issued URGENT MEDICAL DEVICE RECALL (REMOVAL) Letter Products Impacted: Introducer Kit for Impella (sold within Impella Pump sets and Individually Packaged) Axillary Introducer Kits on 11/7/23. Letter states reason for recall, health risk and action to take: IF AN IMPELLA PUMP IS CLINICALLY NEEDED, ACTIONS TO BE TAKEN BY THE USER: 1. Prior to usage, carefully examine the outer pouch of the Introducer Kit for holes following the provided instructions in Attachment 2. 2. For non-trayed introducers (Part Numbers 0052-3006): IF THERE IS ANY SUSPICION OF THIS TYPE OF PACKAGING DAMAGE, REFRAIN FROM USING THE PRODUCT. 3. For trayed introducers with an inner tray package (Part Numbers 0052-3014, 0052-3015, 0052-3021, 0052-3052, 0052-3046, 0052-3025, 0052-3056, 2000342, 0052-3053): Consider that while the outside surface of the tray is non-sterile, the introducers inside the tray are considered sterile. After removing the inner tray from the outer pouch, avoid introducing it to the sterile field. Instead, employ sterile technique to open the inner tray, preserving its interior sterility. a. Transfer the contents from the inner tray to the sterile field following your institution s sterile field management protocol, ensuring no contact with the outer surface to prevent contamination. b. The inner tray must remain separate from the sterile field and should be discarded once all components of the introducer kit have been extracted. 4. If used, document the use on the Business Request Form at the end of this letter. Please contact Abiomed s Clinical Support Center, 1-800-422-8666, if you need any support troubleshooting or if you have any further questions.

Recall details

Recall number
Z-0651-2024
Status
Open, Classified
Initiated by the company
Nov 7, 2023
Posted by the FDA
Jan 5, 2024
Recalling firm
Abiomed, Inc.
Product code
DYB
FDA submissions
K192769
Distribution
Nationwide Foreign: Country AT AU BE BR CA CA CH CZ DE DK ES FR FR HK IN IT MX MY NL NO PA SG TW UK

Product description

Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-0053

Code information (models, lots, serial numbers)

UDI-DI: N/A

Other devices under the same FDA submission

4 devices cleared under K192769 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 93501).

Sources and updates

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