The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1249-2023·Announced 2023-03-22

Plato 17 Microcatheter Recalled Due to Loose Particle Risk

Scientia Vascular is recalling Plato 17 Microcatheters due to manufacturing defects that may introduce loose particles into the catheter lumen, potentially causing blood vessel blockage or inflammatory reactions.

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 involving a medical device with serious potential hazards (embolic events, vessel occlusion) used in critical vascular procedures. No illnesses or injuries are reported, making the hazard theoretical. This qualifies as a high-risk product where injury has not yet been reported per the rubric.

Plain-English summary

Scientia Vascular, Inc. is recalling the Plato 17 Microcatheter in three tip configurations (straight, 45-degree, and 90-degree) due to a manufacturing non-conformance. The defect may cause loose particles to remain inside the catheter's internal channel.

The affected microcatheters were distributed nationwide to medical facilities in 18 U.S. states: Illinois, Alabama, Florida, North Carolina, Wisconsin, Georgia, South Carolina, Indiana, Kansas, California, Ohio, New York, New Hampshire, Colorado, Massachusetts, Nevada, Utah, and Texas. A total of 353 units were distributed.

These devices are used to deliver embolic coils and diagnostic agents to peripheral and neurological blood vessels during medical procedures. The loose particles could potentially cause a blood clot (embolic event), blockage of small blood vessels, or chronic inflammation in the affected area. Patients who received these devices should contact their healthcare provider if they experience symptoms such as swelling, pain, numbness, or changes in circulation. Healthcare providers should verify lot numbers against the recall notice.

The recalled product

Product
Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
Manufacturer
Scientia Vascular, Inc.
Category
Medical Device — Microcatheter / Vascular
Hazard
Affected units
353

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)

  • All lots
  • REF/UDI-DI/Lot(Expiration): PL17-160-000/00818075010455/ 900164(8/31/2022)
  • 900165(8/31/2022)
  • 900172(8/31/2022)
  • 900177(9/30/2022)
  • 900180(9/30/2022)
  • 900186(10/31/2022)
  • 900187(10/31/2022)
  • 900188(10/31/2022)
  • 900193(10/31/2022)
  • 900196(12/31/2022)
  • 900199(12/31/2022)
  • 900202(12/31/2022)
  • 900221(2/28/2023)
  • 900222(2/28/2023)
  • 900225(2/28/2023)
  • 900226(3/31/2023)
  • 20441(11/30/2023)
  • 20476(11/30/2023)
  • 20650(12/31/2023)

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Related recalls

Same manufacturer · Scientia Vascular, Inc.

See all →

Same hazard · embolic event

See all →

Similar recalls