CADD 21-2130-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10610586043628), received between Jul 17, 2020 and May 28, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (3 reports).

6 other recalls cover devices cleared under the same FDA submission (K170982); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2022Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PUMPS WERE NOT COMMUNICATING WITH THE SERVER; THE PUMPS LOST THEIR MAC ADDRESSES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14538509 ↗
• MalfunctionMay 28, 2022Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PUMPS WERE NOT COMMUNICATING WITH SERVER; THEY LOST THEIR MAC ADDRESSES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14538506 ↗
• MalfunctionMay 28, 2022Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PUMPS WERE NOT COMMUNICATING WITH THE SERVER; THEY LOST THEIR MAC ADDRESSES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14538505 ↗
• MalfunctionJul 17, 2020Application Security Problem; Application Security Problem

  THE FOOD AND DRUG ADMINISTRATION NOTIFIED SMITHS MEDICAL THAT THE CADD-SOLIS WIRELESS COMMUNICATION MODULE (WCM) COULD POTENTIALLY BE AFFECTED BY A SET OF VULNERABILITIES IDENTIFIED IN THE CISA CYBERSECURITY VULNERABILITY NOTIFICATION (B)(4). THE RECENTLY PUBLISHED ADVISORY ADDRESSES MULTIPLE VULNERABILITIES AFFECTING EMBEDDED TCP/IP SOFTWARE CREATED BY TRECK INC. THIS TCP/IP STACK HAS BEEN IMPLEMENTED IN A WIDE RANGE OF INDUSTRIES AND PRODUCTS, INCLUDING THE DIGI NET+OS OPERATING SYSTEM USED IN THE CADD®-SOLIS WIRELESS COMMUNICATION MODULE MODEL 2130. SMITHS MEDICAL HAS DETERMINED THAT THE VULNERABILITIES IDENTIFIED IN THE ADVISORY REPRESENT CONTROLLED RISKS TO THE AFFECTED CADD®-SOLIS WIRELESS COMMUNICATION DEVICES AS DEFINED IN FDA GUIDANCE DOCUMENT POSTMARKET MANAGEMENT OF CYBERSECURITY IN MEDICAL DEVICES. THE VULNERABILITIES FOUND IN DIGI NET+OS AND TRECK TCP/IP STACK ARE NOT SPECIFIC OR LIMITED TO SMITHS MEDICAL DEVICES. THERE HAVE BEEN NO CUSTOMER REPORTS OF THE VULNERABILITY BEING EXPLOITED IN THE FIELD. SMITHS MEDICAL HAS RECEIVED A PATCH FROM DIGI, THE SOFTWARE VENDOR, AND WILL RELEASE ADDITIONAL INFORMATION ON THE ISSUE AND FURTHER ACTIONS AS THE SAME BECOMES AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10290804 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170982. One submission often covers many models, so check the product and lot details in each record.

• Z-1662-2025 · Apr 10, 2025 · Open, Classified
  CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope: PUM
• Z-1667-2025 · Apr 10, 2025 · Open, Classified
  CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SO
• Z-1681-2025 · Apr 10, 2025 · Open, Classified
  CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW,
• Z-0466-2025 · Jun 26, 2024 · Open, Classified
  smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps
• Z-2420-2024 · Feb 27, 2024 · Open, Classified
  CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraop
• Z-0963-2023 · Dec 9, 2022 · Open, Classified
  CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8)