Facility

SHAPE MEDICAL SYSTEMS, INC

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3008072932
Establishment type	Manufacture Medical Device
Location	MedTech Center/Shape Medical Systems, In Saint Paul, MN, US 55110
Registration status	Active · expires 2026
Parent company	Shape Medical Systems, Inc (owner-operator 10029892)
Brand names	SHAPE-HF

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (1)

Calculator, Predicted Values, Pulmonary Function
Product code BTY (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.1890

Recalls & enforcement

Class IITerminated2014-12-23
This recall has been initiated because use of the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment. The magnitude of error for VO2 or VCO2 parameters could be approximately 20% with use of the impacted prod…
Class IITerminated2014-05-28
Shape Medical has initiated a correction due to a mandatory software upgrade for the Shape HF Cardiopulmonary Testing System prior to use of the impacted DPI lot numbers. Use of the incorrect software version with the impacted DPIs could result in erroneous testing results poten…

FDA inspections (2)

NAI2023-03-02
No Action Indicated · Compliance: Devices
VAI2019-07-22
Voluntary Action Indicated · Compliance: Devices · citations posted

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.

All facilities operated by Shape Medical Systems, Inc

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)

Cite this record

RegWarden. “SHAPE MEDICAL SYSTEMS, INC (FEI 3008072932) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008072932-shape-medical-systems-inc/

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