Sorin Group Italia SRL - CRF

Complete recall history across all FDA and CPSC categories — 9 total recalls

Sorin Group Italia SRL - CRF appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (9)

FDA medical device enforcement actions by Sorin Group Italia SRL - CRF

Date Product Reason Class
Jul 24, 2017 Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable... There is a possibility of overconsumption of certain PLATINIUM Implantable Ca... Class II
Jul 24, 2017 Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implan... There is a possibility of overconsumption of certain PLATINIUM Implantable Ca... Class II
Jul 24, 2017 Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable... There is a possibility of overconsumption of certain PLATINIUM Implantable Ca... Class II
Jul 24, 2017 Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implant... There is a possibility of overconsumption of certain PLATINIUM Implantable Ca... Class II
Jul 24, 2017 Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implanta... There is a possibility of overconsumption of certain PLATINIUM Implantable Ca... Class II
Jul 24, 2017 Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implant... There is a possibility of overconsumption of certain PLATINIUM Implantable C... Class II
Apr 11, 2017 PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT... Sorin is notifying physicians that certain defibrillators' battery depletion ... Class II
Apr 11, 2017 INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250... Sorin is notifying physicians that certain defibrillators' battery depletion ... Class II
Apr 11, 2017 OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 625... Sorin is notifying physicians that certain defibrillators' battery depletion ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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