Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Balloon Pump; CS300 Intra-A

FDA device recall Z-2414-2011 · posted 2011-06-13 · Terminated

Recall details

Recalling firm

Maquet Datascope Corp - Cardiac Assist Division

Reason for recall

Several models of the Intra-Aortic Balloon Pumps are being recalled due to a potential problem with the fan's assembly which may cause the power supply to detect an overheating event and shut down.

Action taken

Maquet sent an Urgent Product Field Correction letter dated March 16, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to note the WARNING in the IABP Operating Instruction. Customers were advised to refer to the IAB Instructions for Use, Section D (Manually inflating and Deflating a Catheter). Section D of the IAB instruction for Use reiterates that an IAB should not remain inactive for more than 30 minutes and also provides detailed instruction on how to keep an IAB active during IABP failure. Customers were advised that their Service Representatiave would arrange to replace their supply which would contain a new fan assembly. Upon completion of the power supply replacement, customers were asked to sign a service repair order to verify satisfactory completion of the work. For technical questions contact Technical Support Department at 1-800-777-4222 and press 4. For scheduling a service visit by a Field Service Representatiave, contact the firm's US Call Center at 1-800-777-4222 and press 3. Maquet issued a press release on June 6, 2011 advising consumers of the issue and that their recall was considered a class one.

Root cause

Device Design

Status

Terminated

Product code

FMZ

Quantity affected

885 units

Distribution

Worldwide Distribution

Date initiated

2011-03-16

Date posted

2011-06-13

Date terminated

2012-10-25

Location

Mahwah, NJ

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