The Recall Desk
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.

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 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, MAP150
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Hemostasis Valve
Hazard
  • guidewire-entrapment
  • design-defect
  • procedural-delay

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:

  • AK
  • AL
  • AR
  • AZ
  • CA
  • CO
  • DC
  • DE
  • FL
  • GA
  • HI
  • IA
  • ID
  • IL
  • IN
  • KS
  • KY
  • LA
  • MA
  • MD
  • ME
  • MI
  • MN
  • MO
  • MS
  • MT
  • NC
  • ND
  • NE
  • NH
  • NJ
  • NM
  • NV
  • NY
  • OH
  • OK
  • OR
  • PA
  • RI
  • SC
  • SD
  • TN
  • TX
  • UT
  • VA
  • VT
  • WA
  • WI
  • WV

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