Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: packaging-defect
material-degradation
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 →

Same manufacturer · Medtronic

See all →

High
Medtronic Recalls BIOSYN Sutures Due to Potential Incomplete Seal
FDA (Devices) · 2017-06-21
High
Medtronic Recalls USPACK Suture Kits Due to Potential Seal Defects
FDA (Devices) · 2017-06-21
High
Medtronic Recalls Pacemaker Angio X3 Due to Potential Seal Defect
FDA (Devices) · 2017-06-21
Moderate
Medtronic Recalls Polysorb Sutures Due to Potential Incomplete Seal
FDA (Devices) · 2017-06-21
High
Medtronic Recalls Best Practice Kits Due to Potential Seal Defects
FDA (Devices) · 2017-06-21

Same hazard · packaging defect