Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an
FDA device recall Z-1523-2014 · posted 2014-05-21 · Terminated
Recall details
- Recalling firm
- Maquet Datascope Corp - Cardiac Assist Division
- Reason for recall
- Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning.
- Action taken
- Maquet Inc. sent an Urgent Medical Device Field Correction letter dated March 21, 2014, to all affected customers. The letter identified the affected product, problem, and actions to be taken.. Customers were instructed that their Service Representatiave would contact them to schedule the replacement of the fan assembly at no cost to the customer. Upon completion customers were requested to sign a service repair order to verify satisfactory completion of the work. Customers with questions within Puerto Rico, were instructed to contact Technical Support in Mexico at +52-55-9000-8970, ext 104. For questions regarding this recall call 973-709-7652. A field correction letter was sent out on April 15, 2014 to additional consignees that did not receive the March 15, 2014 letter. Maquet issued press on May 9, 2014.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DSP
- Quantity affected
- 11,881 units (US 5183 and OUS 6698)
- Distribution
- Worldwide Distribution - USA (nationwide) and approximately 104 countries.
- Date initiated
- 2014-03-21
- Date posted
- 2014-05-21
- Date terminated
- 2018-03-20
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM (K063525) | Datascope Corp. | 2007-01-05 |
| CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX (K031636) | Datascope Corp. | 2003-08-11 |
| SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP) (K965236) | Datascope Corp. | 1997-07-01 |