Halyard Pacemaker Instrument Packs Recalled for Loose Metal Flakes
AVID Medical is recalling Halyard Pacemaker Instrument Packs (Model VAPX040-01) because sponge forceps and towel clamps may contain loose metal flakes that could detach and enter a patient's surgical site during procedures.
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: This meets the rubric criterion for risk-of-harm products where injury has not yet been reported. The source explicitly states no illnesses or injuries, but surgical site contamination with foreign material represents a credible risk. FDA classified this as Class II.
Plain-English summary
AVID Medical is recalling Halyard Pacemaker Instrument Packs, Model VAPX040-01, distributed nationwide throughout the US. Sponge forceps and towel clamps in these surgical instrument kits may have small loose metal flakes that could potentially detach from the components.
If metal flakes enter a patient's surgical site undetected, they may cause local reactions or foreign body reactions. This represents a potential risk of harm during surgical procedures.
Healthcare facilities and surgical teams currently using these instrument packs should discontinue use immediately. The affected lot number is 1590849 (GTIN: 10809160360798). Contact AVID Medical, Inc., for instructions on returning or replacing the product.
The recalled product
- Product
- Halyard PACEMAKER INSTRUMENT PACK - Medical convenience kits Model Number: VAPX040-01
- Manufacturer
- AVID Medical, Inc.
- 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 (1)
- GTIN: 10809160360798 Lot Number: 1590849
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 73 recalled by AVID Medical, Inc. 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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