The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0904-2022·Announced 2022-04-20

AccessPLUS hemostasis valves recalled for internal guidewire entrapment risk

Merit Medical is recalling AccessPLUS Large Bore Hemostasis Valves due to an internal design gap that can trap guidewires, 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: This is an FDA Class II recall of a medical device with a design defect that impairs intended function. No patient injuries or illnesses are reported, but the defect creates a risk of procedural delay and complications. This falls within the rubric's criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Merit Medical Systems, Inc. is recalling the AccessPLUS Large Bore Hemostasis Valves due to a design change that created an internal gap between the rotator and Y-body. Guidewires can become caught in this gap during use, making it difficult to advance the guidewire through the device.

The defect may result in delays during medical procedures. Approximately 58,963 units have been distributed throughout the United States and internationally.

If you use these devices, check the recalled lot numbers against your inventory. Contact Merit Medical Systems, Inc. for information about device replacement or corrective actions.

The recalled product

Product
AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413…
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Hemostasis Valve
Hazard
Affected units
58,963

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: 580758001/P2073001
  • 580774001/I2219768
  • IN8152/C/H2292361
  • H2287442
  • H2281419
  • H2287443
  • H2298629
  • H2298630
  • H2305054
  • H2281405
  • H2305053
  • H2309362
  • K04-01197/H2296388
  • K05T-01863/T2313699
  • K09-09102B/H2308279
  • K09-10388A/H2285501
  • K09-12917/H2288582
  • K09-13501AP/H2265140
  • K10-05457AP/H2248304
  • H2265127

Distribution

Distributed in 49 states:

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.

See all 2 products in this recall →

Related recalls

Same manufacturer · Merit Medical Systems, Inc.

See all →

Same hazard · guidewire entrapment

See all →

Similar recalls