Datascope System 98/98xt, CS 100/CS100i and CS 300… recallZ-1523-2014 · Maquet Datascope Corp - Cardiac Assist Division · initiated Mar 21, 2014

Why it was recalled

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number

Z-1523-2014

Recall class

Class I (most serious)

Status

Terminated

Initiated by the company

Mar 21, 2014

Posted by the FDA

May 21, 2014

Recalling firm

Maquet Datascope Corp - Cardiac Assist Division

Quantity

11,881 units (US 5183 and OUS 6698)

Product code

DSP

FDA submissions

K031636, K063525, K965236

Distribution

Worldwide Distribution - USA (nationwide) and approximately 104 countries.

Product description

Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.

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