The Recall Desk

Manufacturer

Perouse Medical

4 recalls in our database name Perouse Medical as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2017-05-10

Of the 4 recalls from Perouse Medical we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–4 of 4

  • ModerateFDA (Devices)·Z-1891-2017·2017-05-10

    Perouse Medical Recalls Dolphin Inflation Devices Due to Broken Blister

    Perouse Medical is recalling 18,431 Dolphin Inflation Devices because of complaints regarding broken blisters. The devices were distributed in Arizona, Minnesota, and Tennessee.

    Product
    DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0876-2015·2015-01-07

    Bard Caliber Inflation Device Recalled for Pressure Limitations

    Perouse Medical is recalling Bard Caliber inflation devices that may fail to reach required pressure, potentially delaying angioplasty procedures.

    Product
    Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0877-2015·2015-01-07

    Perouse Medical Recalls Synthes Inflation System Due to Pressure Limitations

    Perouse Medical is recalling 2,184 units of the Synthes Inflation System because the device may fail to raise pressure above 10 atm, potentially delaying procedures.

    Product
    Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to def
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2089-2014·2014-07-30

    Perouse Flamingo Inflation Devices Recalled for Potential Water-Tightness Defect

    Perouse Medical is voluntarily recalling specific batches of Flamingo Inflation Devices due to a potential water-tightness defect that could allow air entry during cardiovascular procedures.

    Product
    Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
    Category
    Medical Device
    Distribution
    0 states