FDA Recalls Multifire VersaTrack Auto Suture Hernia Stapler Due to Assembly Error
The FDA is recalling 12,610 units of the Multifire VersaTrack Auto Suture Hernia Stapler because a manufacturing error may cause staples to fail to advance properly.
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 involves a risk-of-harm product where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 12,610 units of the Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021, manufactured by Covidien Llc. The affected lots are P9J0241Y, P9J0242Y, P9J0243Y, P9K1140Y, P9K1663Y, and P9K1141Y. The product was distributed worldwide.
The recall is due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed. This device is used in endoscopic general surgery procedures for the fixation of mesh in the repair of hernial defects and in other surgical specialties for the approximation of tissues.
Healthcare facilities and distributors should stop using the affected devices and contact the manufacturer for instructions on return or replacement. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).
- Manufacturer
- Covidien Llc
- Hazard
- Affected units
- 12,610
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Covidien Llc 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.
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