The Recall Desk
SevereFDA (Devices)·Z-2159-2018·Announced 2018-06-20

Maquet Aortic Arterial Cannula Recalled for De-airing Plug Breakage Risk

Maquet Cardiopulmonary Ag is recalling specific lots of Aortic Arterial Cannulas because the de-airing plugs may break during removal.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury or structural defects are rated as Severe (4).

Plain-English summary

Maquet Cardiopulmonary Ag is recalling 40 units of Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. The product is intended for use in cardiopulmonary bypass. The recall involves Lot Number 92196585 with UDI Code 04037691085555.

The recall was initiated because this lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula. The agency has classified this as a Class II recall.

The affected units were distributed worldwide, including the US state of Virginia and Puerto Rico, as well as numerous international locations such as Australia, Belgium, Brazil, Canada, and the United Kingdom. Healthcare providers and facilities should identify and stop using the affected units.

The recalled product

Product
Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypass
Manufacturer
Maquet Cardiopulmonary Ag
Category
Medical Device — Cardiopulmonary Bypass
Hazard
Affected units
40

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 (2)

  • UDI CODE: 04037691085555
  • Lot Number: 92196585

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 3 recalled by Maquet Cardiopulmonary Ag under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Maquet Cardiopulmonary Ag

See all →

Same hazard · component breakage

See all →