The Recall Desk
HighFDA (Devices)·Z-2542-2017·Announced 2017-06-21

Medtronic Recalls MAXON Sutures Due to Potential Incomplete Seal

Medtronic is recalling specific MAXON sutures because an incomplete inner package seal may cause the suture material to degrade prematurely.

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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (premature degradation of suture material) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Medtronic is recalling specific MAXON sutures, including MAXON 4/0 5X18" GREEN CV-24 D-TACH, MAXON 5/0 5X18 GR CV-23 D-TACH, and MAXON 4/0 5X30 GREEN V-20 D*TACH. The recall involves a total of 478,465 units. The products were distributed worldwide, including the United States (nationwide including Puerto Rico) and countries such as Australia, Belgium, Canada, Chile, China, Israel, Italy, Japan, South Korea, Mexico, Panama, Saudi Arabia, Singapore, and Turkey.

The recall was initiated due to a potential for an incomplete seal on the inner package. This defect may result in the premature degradation of the suture material. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.

Healthcare providers and consumers should check their inventory for the specific item numbers and lot codes listed in the recall notice. If the affected products are found, they should be removed from use and returned to Medtronic or the appropriate distributor for further instructions.

The recalled product

Product
Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON* 4/0 5X30 GREEN V-20 D*TACH; Item Number: 8886603433
Manufacturer
Medtronic
Category
Medical Device — Surgical Sutures
Hazard
Affected units
478,465

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 8 recalled by Medtronic 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 8 products in this recall →

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