Medtronic Visualase — Class II medical device recall Z-2755-2017
Terminated recall by Medtronic Navigation, Inc., reported 2017-08-02, distributed in CA, FL, GA, IL, MN, NY, TX. Medtronic has become aware that the VCLAS 15MM TIP cap, also referred to as Tuohy Borst Adapter (TBA), may not
| Recall number | Z-2755-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2017-06-07 |
| Classified | 2017-07-21 |
| Reported by FDA | 2017-08-02 |
| Terminated | 2018-06-29 |
| Distributed | CA, FL, GA, IL, MN, NY, TX |
| Quantity | 214 units |
| Reason classes | packaging |
| Lot numbers | 12473141, 211158059, 211158151, 211158152, 211181212, 211181547, 211184941, 211555011, 211555017, 211560973, 211594328, 211599898, 211628257, 211908695, 211916062, 211926889, 211950736, 211959879, 211977586, 211987873, 212127654, 212141557, 212148368, 212434500, 212438405, 212503634, 212504463, 212549456, 212553428, 212632884, 212647830, 212701679, 212707035, 212745660, 212796559, 212912501 |
| Model numbers | 9735561 |
Product
Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1) Cooling Catheter with 3M(TM) SteriStrip(TM), (1) Pump Tubing Set, (1) Drainage Bag. Medtronic Navigation, Inc. Louisville, CO 80027
Reason for recall
Medtronic has become aware that the VCLAS 15MM TIP cap, also referred to as Tuohy Borst Adapter (TBA), may not be capable of creating a seal around the optical fiber to ensure adequate saline flow through the cooling system. When the TBA is unable to seal around the optical fiber, low retention force to the optical fiber may occur, causing saline to leak out of the TBA.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2755-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.