Intracept Access Instruments sterile barrier breach risk
Boston Scientific is recalling Intracept Access Instruments due to potential sterile barrier breach in the outer tray seal, which could introduce infection risk.
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 is an FDA Class II recall involving a high-risk pathogen concern (potential severe infection from sterility breach of surgical instruments). The source text does not report any confirmed illnesses or injuries, and the hazard remains theoretical at present, which limits the score to a maximum of 3 per the rubric.
Plain-English summary
Boston Scientific Neuromodulation Corporation is recalling Intracept Access Instruments, which include multiple reference models (DRILL, 2VB, and 3VB variants). The instruments may have a sterile barrier breach affecting the outer tray seal.
A breach of the sterile barrier could introduce a risk of sterility compromise, potentially leading to severe infection during intraosseous nerve ablation procedures.
The affected devices were distributed worldwide, including throughout the United States and to Great Britain, Germany, and the United Arab Emirates. Affected lot numbers and expiration dates are listed for each reference model variant (RLV0035, RLV0035-EU, RLV0045, RLV0045-EU, RLV0055, RLV0055-EU, RLV0065, RLV0075, and RLV0075-EU).
Customers who have these instruments should stop using affected lots and contact Boston Scientific Neuromodulation Corporation with questions regarding replacement or return.
The recalled product
- Product
- Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU, INTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045, INTRACEPT ACCESS INSTRUMENTS- 2VB EU/RLV0045-EU, INTRACEPT ACCESS INSTRUMENTS…
- Manufacturer
- Boston Scientific Neuromodulation Corporation
- Affected units
- 37,764
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 (20)
- REF/UDI-DI/Lot/Expiration Date Range: RLV0035/852454006240/36231634
- 36266333
- 36266334
- 36266335
- 36442451
- 36556998
- 36577474
- 36577475
- 37355534
- 37374614
- 37642257
- 37642258
- 37667047
- 37667049
- 38711750
- 38711751/04-Mar-2027 to 21-Jul-2027
- RLV0035-EU/852454006448/36267790
- 36909569
- 38889437/04-Mar-2027 to 26-Jun-2027
- RLV0045/852454006301/35218150
Distribution
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