Access-9 Hemostasis Valves Recalled for Guidewire Entrapment Risk
Merit Medical Systems is recalling 36,445 Access-9 Large Bore Hemostasis Valves due to an internal gap that can trap the guidewire, potentially delaying medical 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: FDA Class II medical device with confirmed design defect creating guidewire entrapment risk during use. No injuries or illnesses reported in the source; the hazard is significant but theoretical pending clinical experience.
Plain-English summary
Merit Medical Systems is recalling approximately 36,445 Access-9 Large Bore Hemostasis Valves due to a manufacturing design defect.
The recalled devices contain an internal gap between the rotator and the Y-body component. This gap can cause the guidewire to become caught during use, resulting in difficulty advancing the guidewire through the valve. The defect may cause delays in medical procedures.
The affected devices have been distributed throughout the United States and in multiple countries internationally. Healthcare facilities and providers should identify affected lot numbers and discontinue use of the recalled devices. Replacement devices are available from Merit Medical Systems.
Patients who have undergone procedures using these devices should contact their healthcare provider if they have concerns about their treatment.
The recalled product
- Product
- Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410G, K05-00438G, K05-00502F, K05-00587D, K05-01052, K05-01706C, K05-01880K, K05-02130, K05-02595, K09-12599A, K10-05487P, K12-00264, MAP111/F, MAP112/B, MAP112/F…
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 36,445
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)
- Catalog Code/Lots: 580775001/I2219771
- I2278741
- I2226790
- IN8112/C/H2292357
- H2287440
- H2281404
- H2298626
- H2305047
- H2305048
- H2309356
- K05-00053H/H2305217
- K05-00109G/H2304656
- K05-00137K/H2304653
- K05-00410G/H2305216
- K05-00438G/H2309130
- K05-00502F/H2309122
- K05-00587D/H2309211
- K05-01052/H2304607
- K05-01706C/H2309133
- K05-01880K/H2306962
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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