Prelude SNAP cardiac introducer sheath potentially mislabeled with wrong size
Merit Medical Systems is recalling Prelude SNAP Splittable Sheath Introducers (10F size) because 7F sheaths may have been packaged with 10F labels. This error affects 760 units in lot I2067768.
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: FDA Class II recall with no reported hospitalizations or injuries. The sizing error (7F packaged as 10F) on a cardiac device is a risk-of-harm product where injury has not yet been reported, meeting the criteria for a score of 3 per the rubric.
Plain-English summary
Merit Medical Systems, Inc. is recalling Prelude SNAP Splittable Sheath Introducers (reference PLSX-1010, size 10F, 13 cm standard length) due to a packaging error. 7F sheaths may have been packaged and labeled as 10F sheaths in lot I2067768.
The Prelude SNAP Splittable Sheath Introducer is used for introducing pacing leads and catheters to the heart and coronary venous system during cardiac procedures. Using a 7F sheath when a 10F sheath is expected could compromise the procedure or result in complications.
The recall involves 760 units with lot number I2067768 distributed across the United States and to Norway.
The recalled product
- Product
- Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
- Manufacturer
- Merit Medical Systems, Inc.
- Hazard
- Affected units
- 760
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)
- Lot #I2067768
Distribution
Part of a larger recall action
This product is one of 2 recalled by Merit Medical Systems, 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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