Terumo Puerto Rico LLC

Activity by year

Devices registered here (1)

• Device, Hemostasis, Vascular
  Product code MGB (opens in a new tab) · Class III · Unknown

Recalls & enforcement

• Class IIOngoing2026-06-15
  Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
• Class ITerminated2019-04-26
  There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.
• Class IITerminated2019-02-08
  There is a potential for a loss of package integrity that may compromise the sterility of the product.
• Class IITerminated2018-04-09
  Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore should not be used.
• Class IITerminated2017-09-12
  The tucking depth feature of this catheter introducer is marginally outside the upper specification.
• Class IITerminated2017-06-07
  An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
• Class IITerminated2016-08-04
  During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product specification related to stent diameter at the proximal/distal ends and/or the shape of the stent.
• Class IITerminated2016-03-16
  Terumo Medical is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue. If affected introducer sheaths are used, there is possible risk of incremental blood loss through the valve.
• Class IITerminated2015-11-23
  Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield).
• Class IITerminated2015-11-06
  Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination® products may not contain the labeled 5 cm of coating. While there have been no complaints or patient related incidents reported, the lack of coating could rend…
• Class IITerminated2015-08-05
  According to the Terumo (TMC) this device is used to access the human peripheral vascular system for short term use (less than 30 days) for the purpose of infusing fluids into patients. A small percentage of the catheters in the affected lots may have damage to the ETFE catheter…
• Class IITerminated2013-05-30
  Medical devices were incorrectly labeled with extended expiration dates.

FDA inspections (2)

• VAI2024-07-26
  Voluntary Action Indicated · Compliance: Devices
• NAI2022-08-26
  No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

• All facilities operated by TERUMO MEDICAL CORP.
• Terumo Medical Canada, Inc. (CA)
• TERUMO MEDICAL CORP. (MD)
• TERUMO MEDICAL CORP. (NJ)

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)