The Recall Desk
HighFDA (Devices)·Z-0897-2022·Announced 2022-04-13

Cardiohelp-i Transport Guard Pin Defect May Prevent Device Opening

Maquet Medical Systems is recalling certain Cardiohelp-i Transport Guard units due to a potential loose cylindrical pin that may jam the locking mechanism. This could prevent the device from opening or cause complete disassembly, potentially delaying critical cardiac support.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a life-support device used during cardiac surgery. Although no injuries have been reported, the potential for the device to malfunction and prevent opening qualifies as a risk-of-harm product per the rubric, supporting a severity score of 3 (High).

Plain-English summary

Maquet Medical Systems USA is recalling certain Cardiohelp-i Transport Guard units (Product Code 701072780). The Cardiohelp-i is a blood oxygenation and carbon dioxide removal system used to support circulation and lung function during cardiopulmonary bypass procedures, which can last up to six hours.

The recall addresses a potential defect involving a loose cylindrical pin in the Transport Guard assembly. This loose pin may cause the locking mechanism to jam, preventing the Transport Guard from opening. In severe cases, the pin may become fully disengaged, causing complete disassembly of the Transport Guard.

In the United States, 32 units were distributed to hospitals and medical centers in Florida, Kentucky, New Hampshire, New Jersey, New York, Pennsylvania, Texas, and Virginia. An additional 30 units were distributed internationally to Belgium, Canada, Germany, Hungary, Luxembourg, Malaysia, Mexico, Poland, Slovakia, South Africa, South Korea, and Taiwan. Affected facilities with these serial numbers should contact Maquet Medical Systems USA for further guidance on inspection, replacement, or remediation.

The recalled product

Product
Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up t
Manufacturer
Maquet Medical Systems USA
Category
Medical Device — Cardiac Support Equipment
Hazard
  • loose-pin
  • jamming
  • disassembly

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 90414225
  • 90414226
  • 90414227
  • 90414228
  • 90414229
  • 90414232
  • 90414233
  • 90414234
  • 90414235
  • 90414236
  • 90414237
  • 90414283
  • 90414284
  • 90414285
  • 90414286
  • 90414287
  • 90414288
  • 90414289
  • 90414292
  • 90414293

Distribution

Distributed nationwide across the United States.

Related recalls

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