Stryker Diagnostic Electrophysiology Catheters Recalled for Testing Failure
Stryker Sustainability Solutions is recalling 6 units of BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters because they do not meet FDA testing requirements. The devices were distributed to Japan.
What this means for you
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 FDA Class II medical device recall involves catheters that fail to meet required testing standards. Although no adverse events have been reported, the failure to meet testing requirements represents a risk-of-harm product where injury has not yet been reported, warranting a High severity classification.
Plain-English summary
Stryker Sustainability Solutions is recalling BW Lasso 2515 NAV eco Variable Diagnostic Electrophysiology (EP) Catheters (Model D134301, 22 electrodes, 2–6–2 mm spacing, 115 cm length, sterile). The recall involves 6 units with the following serial numbers: 4175411, 4202651, 4116975, 4202652, 4175410, and 4175402.
The catheters do not meet FDA testing requirements. This failure to meet required testing standards raises concerns about the device's performance and safety in its intended use for diagnostic electrophysiology procedures.
The affected catheters were distributed to Japan. Customers who received these products should contact Stryker Sustainability Solutions immediately for instructions regarding the recalled devices. Healthcare providers should not use the recalled units.
The recalled product
- Product
- Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- Affected units
- 6
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 (6)
- (UDI):00885825011680/Serial #: 4175411
- 4202651
- 4116975
- 4202652
- 4175410
- 4175402
Distribution
Distribution scope not specified by the agency.
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