Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic… recallZ-2414-2011 · Maquet Datascope Corp - Cardiac Assist Division · initiated Mar 16, 2011

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number

Z-2414-2011

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Mar 16, 2011

Posted by the FDA

Jun 13, 2011

Recalling firm

Maquet Datascope Corp - Cardiac Assist Division

Quantity

885 units

Product code

FMZ

FDA submissions

K031636, K063525, K965236

Distribution

Worldwide Distribution

Product description

Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Balloon Pump; CS300 Intra-Aortic Balloon Pump; Manufactured by Datascope Corp., 1300 MacArthur Blvd., Mahwah, NJ 07430 The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloon. It provides temporary support to the left ventricle via the principle of counterpulsion. The IABP is placed in the descending aorta, via the principe of counterpulsation. The IABP is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the IABP is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle. The CS300 has the additional capability to automatically calibrate a fiber-optic pressure sensor placed in the tip of the intra-aortic balloon. The IABP will recalibrate every 2 hours or sooner should the patient or environmental conditions change. The target populations are adult and pediatric. The IABP is intended for use in the health care facility setting.

Other devices under the same FDA submission

21 devices cleared under K031636, K063525, K965236 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• CS100 Intra-Aortic Balloon Pump, English, 220V 0998-00-3013-55

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  4 deaths933 reports
• CS100 Intra-Aortic Balloon Pump, Chinese, 220V 0998-00-3013-45

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  2 deaths684 reports
• CS100 Intra-Aortic Balloon Pump, Refurbished, ENGLISH,NON-UTS,INTL 0998-UC-3013-55

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 death129 reports
• CS100 Intra-Aortic Balloon Pump, Japanese, 110V 0998-00-3013-65

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall1 death60 reports
• CS100 Intra-Aortic Balloon Pump, Spanish, 220V 0998-00-3013-58

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall32 reports
• CS100 Intra-Aortic Balloon Pump, Portuguese, 110V 0998-00-3013-69

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  66 reports
• CS100 Intra-Aortic Balloon Pump, Italian, 220V 0998-00-3013-67

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  65 reports
• CS100 Accessory Kit, Spanish, 220 V 0020-00-0463-05

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  1 recall0 reports
• CS100 Intra-Aortic Balloon Pump, Portuguese, 220V 0998-00-3013-68

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  49 reports
• CS100 Intra-Aortic Balloon Pump, French, 220V 0998-00-3013-64

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  16 reports
• CS100 Intra-Aortic Balloon Pump, Refurbished, CHINESE,NON-UTS,INTL 0998-UC-3013-45

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  13 reports
• CS100 Intra-Aortic Balloon Pump, Refurbished, JAPANESE,NON-UTS,DOM 0998-UC-3013-65

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  11 reports