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Reinforced Introducer Sets Maquet 8 Fr., Part Number:… recallZ-0934-2020 · Datascope Corporation · initiated Nov 20, 2019

Terminated

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 Datascope Corporation 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

Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.

FDA root cause category: Package design/selection

What the company is doing

On December 11, 2019 the firm distributed Urgent Medical Device Recall Communication letters by FedEx 2 day delivery with signature proof of delivery stating: URGENT MEDICAL DEVICE RECALL REMOVAL MAQUET 7Fr., 7.5Fr. and 8Fr. REINFORCED INTRODUCER SETS PLEASE FORWARD THIS INFORMATION TO ALL CURRENT AND POTENTIAL USERS OF REINFORCED INTRODUCER SETS FOR MAQUET 7 Fr., 7.5 Fr. AND 8 Fr. INTRA-AORTIC BALLOON (IAB) WITHIN YOUR HOSPITAL OR FACILITY. IF YOU HAVE FURTHER DISTRIBUTED ANY OF THE AFFECTED PRODUCTS, FORWARD THIS INFORMATION TO THE RECIPIENT. Dear Risk Manager, Datascope / Maquet Getinge is initiating a voluntary Medical Device Recall Removal of the Reinforced Introducer Sets for Maquet 7 Fr., 7.5 Fr.and 8 Fr. IAB (Intra Aortic Balloon) due to a potential breach in the Mylar side (clear plastic) of the pouch, which could compromise device sterility. Identification of the issue: During the execution of a remediation protocol for re-verification of packaging, Datascope / Maquet Getinge found a small slit on the Mylar side (clear plastic) of the pouch of one device. Imprints of the sharp corners of the polystyrene strip used in packaging were observed around the slit, which likely caused the breach in the pouch compromising the sterility of the device. Risk to Health Adequate packaging and packaging materials are essential to help preserve the sterility of medical devices. Improperly sterilized medical devices may pose a serious risk of patient infection, including pyrogenic reaction, inflammatory response, and the possibility of a deadly infection. The probability of serious injury or illness occurring as a result of this potential issue is unlikely, however, likelihood is greater for immunocompromised patients. To date, Datascope / Maquet Getinge has not received any complaints, nor have any adverse events been reported resulting in serious illness or injuries caused by the Reinforced Introducer Set for Maquet 7 Fr., 7.5 Fr.

Recall details

Recall number
Z-0934-2020
Status
Terminated
Initiated by the company
Nov 20, 2019
Recalling firm
Datascope Corporation
Quantity
523
Product code
DSP
Distribution
US: AK AL AZ CA CO CT FL GA IA ID IL IN KS KY LA MD MI MN MO MS NC ND NE NJ NY OH OK PA SC SD TN TX VA WA WI WV OUS: Switzerland, Netherlands, South Africa, Canada, Germany, Austria, Spain, Italy, Poland, Bharain, Malaysia

Product description

Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.

Code information (models, lots, serial numbers)

Part Number: 068400040310 UDI: 10607567107943 (068400040310) Lot Codes: 3000079612, 3000043101, 3000036631, 3000015016, TTP.

Devices named in this recall

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

Other products in the same recall event

The FDA groups related products into one recall event (event 84521).

Sources and updates

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